Drugs / Seltorexant
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 124 trials · 1 met primary | ||||||
| Phase 1 | NCT05236868 | Feb → Mar 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05106153 | Dec 2021 → May 2023 | substance abuse | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04951609 | Sep 2021 → Apr 2024 | major depressive disorder | Janssen Research & Development, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04960124 | Aug → Nov 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04616677 | Mar 2021 → Oct 2022 | impaired renal function disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04553042 | Sep → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04451187 | Jul 2020 → Mar 2023 | major depressive disorder | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03796026 | Jan → Jun 2019 | obstructive sleep apnea syndrome | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03682380 | Oct 2018 → Aug 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03494907 | Apr → Aug 2018 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03438461 | Feb → May 2018 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03374475 | Jan 2018 → Apr 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 1 | NCT03249402 | Aug → Nov 2017 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT03025022 | Jan → Feb 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02837692 | Jun 2016 → Sep 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02661893 | Jan → Feb 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02578472 | Nov 2015 → Feb 2016 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT02617810 | Nov 2015 → Feb 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02555124 | Sep → Oct 2015 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02476058 | Jun 2015 → Jan 2016 | major depressive disorder | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT02475161 | Jun → Jul 2015 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02455856 | May → Jun 2015 | — | Janssen Cilag N.V./S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02230878 | May → Nov 2014 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT02067299 | Feb → Dec 2014 | major depressive disorder | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT05307692 | May 2022 → Nov 2023 | Alzheimer disease | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT03321526 | Dec 2017 → Jun 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT03375203 | Nov 2017 → Apr 2019 | insomnia | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT03227224 | Aug 2017 → Jan 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02464046 | Jul → Dec 2015 | insomnia | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 35 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT07573176 | Apr 2026 → Aug 2028 expected | major depressive disorder | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06559306 | Jul 2024 → Dec 2026 expected | major depressive disorder | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04533529 | Sep 2020 → Apr 2023 | major depressive disorder | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT04532749 | Sep 2020 → May 2022 | major depressive disorder | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 3 | NCT04513912 | Sep 2020 → Oct 2023 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-09-22 | Janssen Research & Development, LLC | Results Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR jnj.com ↗
Seltorexant and quetiapine XR showed large and clinically meaningful improvements in depressive symptoms (-23.0 and -22.7, respectively), as measured by change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline. |
| 2025-09-15 | Janssen Research & Development, LLC | Results Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting jnj.com ↗ |
| 2024-10-24 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress jnj.com ↗
Adjunctive Treatment with Seltorexant Improved Patient-Reported Depressive Symptoms, Insomnia Symptoms, and Overall Health in Major Depressive Disorder with Insomnia |
| 2024-10-24 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress jnj.com ↗
Adjunctive Treatment with Seltorexant Improved Patient-Reported Depressive Symptoms, Insomnia Symptoms, and Overall Health in Major Depressive Disorder with Insomnia |
| 2024-05-29 | Janssen Research & Development, LLC | Results Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes jnj.com ↗
Johnson & Johnson announced today positive topline results from the pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms. |
| 2024-05-29 | Janssen Research & Development, LLC | Results Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes jnj.com ↗
Johnson & Johnson announced today positive topline results from the pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms. |
| 2019-08-05 | Minerva Neurosciences | Results Minerva Neurosciences Reports Second Quarter 2019 Financial Results and Business Updates minervaneurosciences.com ↗
In addition, in a recent biomarker study with seltorexant, we demonstrated mood improvements in MDD patients when seltorexant was given as monotherapy. |
| 2019-06-24 | Minerva Neurosciences | Results Minerva Neurosciences Announces Achievement of Primary and Key Secondary Objectives in Phase 2b Clinical Trial of Seltorexant (MIN-202) in Insomnia minervaneurosciences.com ↗
Primary endpoint, defined as Latency to Persistent Sleep (LPS) at Night 1, showed improvement with a p-value ≤0.001 after treatment with 10 and 20 mg doses of seltorexant |
| 2019-06-23 | Minerva Neurosciences | Results Minerva Neurosciences to Host Live Conference Call and Webcast With Key Opinion Leaders to Discuss Successful Insomnia Trial With Seltorexant minervaneurosciences.com ↗
Call scheduled for 8:30 a.m. Eastern Time on June 24 to review results of successful Phase 2b trial showing achievement of primary and secondary endpoints with potential first-in-class specific orexin- 2 receptor antagonist for the treatment of insomnia |
| 2019-05-13 | Minerva Neurosciences | Results Minerva Neurosciences Announces Positive Top Line Results in Phase 2b Clinical Trial With Seltorexant (MIN-202) in Treatment of Depressed Patients With an Inadequate Response to SSRIs and SNRIs minervaneurosciences.com ↗
In this dose finding study, the 20 milligram (mg) dose of seltorexant, under co-development with Janssen Pharmaceutica NV , showed a statistically significant improvement in the MADRS (Montgomery-Asberg Depression Rating Scale) score compared to placebo. |
| 2016-03-11 | Minerva Neurosciences | Results Minerva Neurosciences Announces Positive Top Line Results From Phase Ib Clinical Trial in Major Depressive Disorder With MIN-202 minervaneurosciences.com ↗ |
| 2016-02-01 | Minerva Neurosciences | Results Minerva Neurosciences Announces Top Line Data From MIN-202 Phase I Clinical Study in Japanese Patients minervaneurosciences.com ↗
It was observed that single dose morning administration of MIN-202 was well tolerated at all three dose levels tested, 5 milligrams (mg), 20 mg and 40 mg. |
| 2016-01-11 | Minerva Neurosciences | Results Minerva Neurosciences Announces Favorable Top Line Results From MIN-202 Phase 2A Clinical Trial in Insomnia Disorder minervaneurosciences.com ↗
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders, today announced favorable top line results from a Phase 2A clinical trial in insomnia disorder with MIN-202 (JNJ-42847922), a selective orexin-2 receptor antagonist under joint development with Janssen Pharmaceutica NV. |
| 2015-06-16 | Minerva Neurosciences | Regulatory Minerva Neurosciences Provides Update on MIN-202, Selective Orexin-2 Receptor Antagonist minervaneurosciences.com ↗
IND Now in Effect to Expand Clinical Testing into Adjunctive Major Depressive Disorder |
All press releases naming this drug 23 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Seltorexant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04533529 ↗ |
| Known as | JNJ-42847922 | “Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the treatment of adjunctive treatment of MDD...” NCT04951609 ↗22“A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and...” NCT03438461 ↗ “Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the adjunctive treatment of MDDIS.” NCT04532749 ↗ “The purpose of this study is to evaluate the safety and tolerability of JNJ-42847922 in participants with Major Depressive Disorder (MDD).” NCT02476058 ↗ “Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R)” NCT04513912 ↗ |
| Known as | MIN-202 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3597971 ↗ |
| Action | Inhibit | “Seltorexant is a potent and selective antagonist of the orexin-2 receptor” PMID 29848147 ↗ May 20181“Orexin receptor 2 antagonist” CHEMBL3597971 ↗ |
| Modality | Small molecule | — CHEMBL3597971 ↗ |
| Route | Oral | “orally on Day 1” NCT02067299 ↗ |
| Target | HCRTR2 | “Orexin receptor 2 antagonist” CHEMBL3597971 ↗ |